The Impact of GLP-1s on Cardiovascular Clinical Development

In this webinar, the panel of experts will discuss recent advancements in cardiovascular clinical development. The incidence and prevalence of type 2 diabetes mellitus (T2DM) and cardiovascular diseases such as heart failure are increasing worldwide, resulting in the need to not only bring forward new treatments but to better understand existing treatments, such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs), and their potential applications in cardiovascular disease and cardiovascular kidney metabolic (CKM) syndrome.

Future successful study outcomes will depend on applying lessons learned over the last 20 years of developing GLP-1s to new therapeutic areas in cardiovascular disease, as well as exploring cardiac and renal endpoints in non-diabetic patients, both with and without cardiovascular disease.

The featured speakers will also discuss the increasing moral, scientific and regulatory requirements to increase access to cardiovascular clinical trials for populations historically underserved by the clinical research community since these diseases disproportionately impact disadvantaged and minority populations. The panel will consider efforts to diversify clinical trials in the cardiovascular space and explore what else should be done to meet this need.

Join this webinar to gain an understanding of the potential application of GLP-1 RAs in the treatment of cardiovascular indications, how the landscape for cardiovascular clinical research is changing, and what this means for the future of cardiovascular clinical trials.

Speakers

Adrienne Richards, MD, Medical Science and Strategy Lead, Cardiovascular, PPD clinical research business, Thermo Fisher Scientific

Adrienne L. Richards, M.D. is a Medical Director in Pharmacovigilance and former practicing cardiologist with a solid foundation in basic pharmaceutical research and a clinical research background dating back 30 years that includes industry experience supporting Phase I to Phase IV trials. Her pharmaceutical experience began at Drew University as a Chemistry major working with the Director of the RISE Institute, Dr. George deStevens (Ciba-Geigy), on the stereochemistry of novel heterocyclic compounds. As a medical student at The Johns Hopkins University School of Medicine (1986-91), she completed an additional year at Brigham and Woman’s Hospital, Boston, MA, (1989-90) as a Fellow of the Stanley J. Sarnoff Research Foundation of Cardiovascular Science and was awarded The Dr. Harold Lambert Biomedical Research Prize (1991) for her work with TPA and membrane kinetics. After completing a medical internship at Cornell Medical Center, she finished a medical residency and cardiology fellowship at Duke University Medical Center via the Clinical Investigator Pathway (1992 -97).  She worked for nine years in clinical practice as a non-invasive cardiologist before joining the pharmaceutical industry as a CRO medical director.

Over the last 13 +  years in the CRO industry, she has supported Phase I to IV trials as a regional and global medical monitor, including multiple large, global cardiovascular outcomes trials and others which encompass an ever-expanding cardiac therapeutic focus.  She has supported protocol development, trial execution, upstream program design, and risk/benefit analyses of marketed therapeutics.  In 2015 she received the PPD CEO Leadership Excellence award and most recently was appointed Global Cardiovascular Therapeutic Area Lead of our team of cardiologists.  As her role has grown at PPD since 2014 and as a Medical Science and Strategy Global Lead, she has been instrumental in the growth of Biotech strategy and delivery of first-in class therapeutics for the unmet needs that are a focus of further development in cardiovascular medicine.

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Rose Blackburne, MD, Therapeutic Area Head, Medical Science and Strategy, PPD clinical research business, Thermo Fisher Scientific

Dr. Rose Blackburne is a globally recognized leader in product development and a board-certified Obstetrics/Gynecology Physician with over 25 years of experience in healthcare. She currently serves as the Global Vice President and Therapeutic Area Head of General Medicine for the PPD clinical research business of Thermo Fisher Scientific. In this role, Dr. Blackburne has been instrumental in obtaining approvals for pharmaceuticals, vaccines, medical devices and diagnostic tests. She also serves as the industry representative alternate to the FDA Patient Engagement Advisory Committee (PEAC), providing advice on medical device regulation and developing guidance and policies.

With over 18 years of experience in clinical research & development, Dr. Blackburne has held numerous global leadership positions in CRO, focusing on Phase I-IV programs across therapeutic areas. She is passionate about diversity, equity and inclusion and women’s health policies, and has led numerous initiatives to improve the inclusion of underrepresented participants in clinical trials. Dr. Blackburne holds a medical degree from Morehouse School of Medicine, an MBA from the University of Virginia Darden Graduate School of Business and a certificate in health policy from Harvard University Kennedy School of Government.

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Marlena Erikson, Senior Director, Project Oversight, PPD clinical research business, Thermo Fisher Scientific

Marlena Erikson is a motivated, customer- focused senior director within project delivery with more than 20 years of experience in the clinical research and pharmaceutical industry. Her depth of experience managing clinical trials consists of all phases of trials, including the implementation of study protocols and programs. Clients know to expect sincere commitment and open communication from Marlena, while working to build strong teams, for the attainment and successful completion of study deliverables while meeting timelines and budget expectations.

Throughout her career, Marlena has specialized in studies that include the following indications: ischemic heart disease, peripheral arterial disease, critical limb ischemia and wound healing, hypercholesterolemia, cardiovascular imaging, pericarditis, amyloid transthyretin (ATTR) amyloidosis, diabetes, diabetic foot ulcer and neuropathy, cell and gene therapy, and rare diseases.

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(Moderator) Paul Collins, Executive Director and Cardiovascular Pillar Head, PPD clinical research business, Thermo Fisher Scientific

With more than 25 years of clinical research experience, Paul Collins has been a member of the business’ project delivery team for 15 years. In addition to his passion for delivering excellence and innovation in drug development studies, he possesses proven strengths in building strong, high-performing teams, productive and meaningful relationships with sponsors and internal stakeholders and excellent financial and commercial acumen.

Prior to joining the cardiovascular therapeutic unit, Paul spent 14 years in the hematology and oncology therapeutic unit, with five years as a member of the biopharma leadership team overseeing two key biopharma partner portfolios and managing a team of oversight directors. He also led workstreams in digital and decentralized trials and cell therapy logistics, conducting project risk review meetings/interviews and served as a mentor and support to members of the wider team.

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